Amarin Corp Plc (AMRN)

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The KRAKEN clinical trial included 233 adults around the world who were identified at high risk of having a cardiovascular event due to very high Lp(a) levels (greater than 175 nmol/L). Researchers evaluated the effects of muvalaplin at different doses—10 mg, 60 mg or 240 mg, taken daily—compared with a daily placebo for 12 weeks. The researchers tested Lp(a) levels using both the traditional Lp(a) blood test and a new test that more specifically measures the levels of intact Lp(a) particles in the blood.

At week 12, the study found:

Compared to placebo, muvalaplin treatment reduced Lp(a) by up to 70% as measured by the traditional blood test, and by up to 85.5% as measured by the new intact Lp(a) particle test. Participants who received either 60 or 240 mg of muvalaplin had similar reductions in Lp(a) levels, both of which were greater than the reductions in Lp(a) levels of participants who received 10 mg of muvalaplin.
Muvalaplin treatment resulted in approximately 97% of participants achieving Lp(a) lower than 125 nmol/L, as measured by the intact Lp(a) particle test, or approximately 82% of participants as measured with the traditional blood test.
Compared to placebo, muvalaplin lowered apoB, one of two major proteins that make up Lp(a), by as much as 16%, with no notable change in levels of high-sensitivity C-reactive Protein (hsCRP), which is a way to measure heart attack and stroke risk.
“We were encouraged by the degree of Lp(a)-lowering in these patients who are most likely to benefit from its use and by the safety and tolerability,” Nicholls said. “While muvalaplin appears to be an effective approach to lowering Lp(a) levels, we still need to study whether Lp(a) lowering will result in fewer heart attacks and strokes.”

The study had limitations, including that it was relatively small and trial participants were treated for only 12 weeks. “Larger, more diverse and longer-term studies are needed,” Nicholls noted.